Neurochem submits FDA application for kidney drug Fibrillex

By Elaine Rigoli

Tampa, Fla., Feb. 13 - Neurochem (International) Ltd. announced Monday that it has submitted to the Food and Drug Administration the final modules of its application for eprodisate (Fibrillex).

Eprodisate is designated as an orphan drug, is a fast-track product candidate and is also part of FDA Continuous Marketing Application pilot 1 and pilot 2 programs.

As a means of preserving kidney function, the company claims that this treatment has the potential to provide a much needed therapeutic solution for patients suffering from Amyloid A (AA) amyloidosis. A progressive and fatal condition, AA amyloidosis occurs in patients with chronic inflammatory disorders, chronic infections, and inherited diseases such as Familial Mediterranean Fever. AA amyloidosis typically causes kidney problems, with progression to dialysis and end stage renal disease the most common cause of death.

Neurochem enrolled 183 patients suffering from AA amyloidosis for its phase 2 and 3 trials, which were conducted over two years at 27 sites located across North America, Europe, and Israel.

Neurochem has an exclusive collaboration and distribution agreement for Fibrillex with Centocor, Inc.

Neurochem (International) is a wholly owned subsidiary of Laval, Quebec-based Neurochem, a company focused mostly on neurological disorders.

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